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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03857061
Other study ID # 18-5462
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 29, 2019
Est. completion date December 30, 2023

Study information

Verified date May 2023
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with Chronic Obstructive Pulmonary Disease (COPD), which provides them with appropriate self-management tools and detects AECOPDs early to permit prompt treatment and prevent severe exacerbations requiring hospitalization.


Description:

Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with COPD, which provides them with appropriate self-management tools and detects Acute Exacerbations of COPD (AECOPDs) early to permit prompt treatment and prevent severe exacerbations requiring hospitalization. Currently, the investigators are developing a second version of this app, WearCOPDv2. This app will incorporate features identified as being desirable from our patient interviews: 1) new sensor that was requested by patients - oxygen saturation, and 2) the app will incorporate a patient-facing interface as patients requested a method to view their data as well as access to information to learn how to manage their condition better. Research questions: Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD? What is the accuracy of our sensor data (heart rate, activity, respiratory rate, oxygen saturation, coughing, and other sounds of interest) in detecting early AECOPDs?


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 30, 2023
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - Able to speak English - Moderate to very severe COPD (GOLD C and D) as defined by the GOLD guidelines - Clinically relevant disease, as defined by a history of exacerbation in the previous 12 months - Previous spirometry or Pulmonary Function Test results of Forced Expiration Volume/Forced Vital Capacity (FEV1/FVC) <0.70 with an FEV1 below 80% predicted - Patient resides at home (not long term care residence or another hospital) Exclusion Criteria: - Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma - Rapid lethal disease, e.g. lung cancer, advance heart failure, end-stage renal disease - Any medical conditions that would impair their ability to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
smartphone, smartwatch, WearCOPDv2 application
WearCOPD2 consists of hardware and software components. 6.1 Hardware The hardware for wearCOPDv2 consists of three main components; (1) a smartwatch, (2) a phone, and (3) a server. 6.2 Software The wearCOPDv2 system has two main software components: Data collection service Participant user interface

Locations

Country Name City State
Canada Toronto General Hospital Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
University Health Network, Toronto Samsung Electronics, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in self-management as measured by the Mastery sub-section of the Chronic Respiratory Disease Questionnaire Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD?
We will use the Mastery sub-section of the Chronic Respiratory Disease Questionnaire to measure our research question. Mastery is measured with a 7-point likert scale where higher scores indicate better health-related mastery.
6 months
Secondary Change in self-efficacy as measured by the COPD Self-Efficacy Scale Can an app designed for patients with COPD that includes biosensor feedback improve self-efficacy of COPD?
This will be measured by the COPD self-efficacy scale. Participants will determine how confident they are that they could manage breathing difficulty or avoid breathing difficulty in certain situations. Usin the following scale.
Very confident
Pretty confident
Somewhat confident
Not very confident
Not at all confident
A lower score indicates higher self-efficacy.
6 months
Secondary Change in Health related quality of life as measured by the St. George's respiratory questionnaire Can an app designed for patients with COPD that includes biosensor feedback improve health related quality of life?
Scoring and Scales
Questions 1 - 7 Scale: Most days a week - Not At All
Where a patient has ticked a box, a value of 1 is entered for the appropriate question.
Question 8 Where a patient has ticked 'Yes' to having a worse wheeze in the morning, a value of 1 is entered for the appropriate question.
Questions 9, 10 & 17 Where a patient has ticked a box, a value of 1 is entered for the appropriate question.
Questions 11 - 16 Where a patient has ticked 'True' a value of 1 is entered for the appropriate question.
In response to question 14, if a patient is not receiving medication, enter the responses as zero.
Score = 100 x (Summed weights from positive items in the questionnaire divided by the Sum of weights for all items in the questionnaire)
lower scores indicate higher health related quality of life
6 months
Secondary Change in symptom scale as measured by the MRC dyspnea scale Can an app designed for patients with COPD that includes biosensor feedback improve COPD symptoms?
The MRC Dyspnea scale asks you to rate your breathlessness on a 5 point likert scale.
6 months
Secondary Accuracy of our derived prediction algorithm to detect acute exacerbations as measured by the daily symptom score. We will correlate sensor data from the smartwatch to exacerbations defined by the daily symptom score.
The daily symptom score asks about daily symptoms of COPD and patients are asked to answer yes or no to whether or not they have experienced a decline of any of the symptoms
6 months
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